A multicentric phase II clinical trial on intra-arterial hepatic radiotherapy with 90yttrium SIR-spheres in unresectable, colorectal liver metastases refractory to i.v. chemotherapy: preliminary results on toxicity and response rates.

BACKGROUND: In patients locally progressing after two lines of chemotherapy, some locoregional approaches showed encouraging results in terms of local control of disease. The aim of our study was to evaluate toxicity, clinical response and quality of life in 48 patients with unresectable colorectal liver metastases submitted to selective internal radiotherapy (SIRT). MATERIALS AND METHODS: Up to now 35 patients with unresectable colorectal liver metastases, refractory to two lines of chemotherapy, underwent intra-arterial infusion of resin microspheres with yttrium-90 (SIR-spheres). Pre-treatment evaluation included a CT scan, blood tests, a PET scan and arteriography of celiac trunk, hepatic and superior mesenteric artery; extrahepatic uptakes and pulmonary shunts more than 10% were excluded by a Scinti-scan. The gastroduodenal artery was embolized before the SIR-spheres injection. Other exclusion criteria were liver dysfunction and anatomical vascular anomalies. The clinical response was evaluated by CT-scan following the RECIST criteria. Median follow-up was 4 months. RESULTS: Median number of metastases was 4 (range, 1-15), 38% of cases presenting hepatic involvement < 25%. The median SIRT dose delivered was 1.7 GBq. Median pulmonary shunt was 6%. No operative mortality occurred; early toxicity (within 48 hours) was 20.6%, shown as fever, acute pain and leucocytosis. The late toxicity was 24.1% with chronic pain, jaundice and nausea being the most frequent. All the toxic events were graded 2 or 3 according to the WHO scale. Preliminary results were available in terms of clinical response after 6 weeks: 12.5% had a partial response, 75% a stable disease, while progression of disease, was observed in 12.5% of the patients. CONCLUSION: SIRT is a safe treatment in terms of acute and late toxicity. Intra-arterial microspheres could represent a good therapeutic option for patients with progressing liver metastases only, after two lines of systemic chemotherapy.

Serum thyroglobulin concentrations and (131)I whole-body scan results in patients with differentiated thyroid carcinoma after administration of recombinant human thyroid-stimulating hormone.

UNLABELLED: The use of recombinant human thyroid-stimulating hormone (rhTSH) has recently become available as an alternative diagnostic tool to assess the persistence and recurrence of differentiated thyroid carcinoma (DTC) in patients on thyroid hormone-suppressive therapy (THST) after near-total or total thyroidectomy and ablative doses of (131)I. We report the results of rhTSH administration in patients who were monitored for DTC. METHODS: Thirty-three adult DTC patients (13 men, 20 women; mean age +/- SE, 45.6 +/- 2.31 y; age range, 21-65 y) underwent diagnostic follow-up after rhTSH administration at a dose of 0.9 mg once a day for 2 d. Whole-body scanning and serum thyroglobulin (Tg) measurement were performed after rhTSH administration. Patients were divided into 2 groups depending on serum Tg concentrations on THST: 29 patients had Tg concentrations of <2 ng/mL (group A) and 4 patients had Tg values of >2 ng/mL (group B). RESULTS: In group A, Tg values remained at <2 ng/mL in 25 patients and increased from 1.1 +/- 0.14 ng/mL to 22.0 +/- 5.75 ng/mL (mean +/- SE) in 4 patients after rhTSH administration. Whole-body scanning did not reveal any uptake of (131)I in the 25 patients without an increase in Tg, whereas (131)I uptake was evident in 2 of the 4 patients with a rise in Tg. In group B, Tg values increased in all 4 patients from 17.3 +/- 6.35 ng/mL to 55.3 +/- 12.75 ng/mL, and (131)I uptake was evident in 3 of the 4 patients. No major adverse effects were reported after rhTSH administration. CONCLUSION: Our results show that the measurement of serum Tg concentrations after rhTSH has a higher diagnostic value than whole-body scanning in detecting the persistence of thyroid tissue. Therefore, rhTSH should be administered in TSH-suppressed patients with basal serum Tg concentrations of <2 ng/mL because the increment in serum Tg concentrations may reveal the persistence of thyroid tissue in these patients.

[Transcutaneous radiotherapy after thyroidectomy for differentiated thyroid carcinoma]. / La radioterapia transcutanea dopo tiroidectomia per carcinoma tiroideo differenziato.

PURPOSE: To compare the results, in terms of 10-year actuarial survival, between I-131-therapy and I-131-therapy + external beam radiotherapy (RT) in patients operated on for differentiated thyroid carcinoma. PATIENTS AND METHODS: Over a period of 13 years (1982-1995) 408 patients underwent thyroidectomy with or without linphoadenectomy for pT0/T4 Nx or pN0, pN1a, pN1b thyroid carcinoma. In all cases, thyroidectomy was radical. Patients were divided into two groups, which were comparable according to several prognostic factors: group A composed of 165 patients (surgery + I-131) and group B, 243 patients (surgery + I-131 + RT). RESULTS: The percentage of deaths related to relapsed or metastatic thyroid carcinoma was 6.25%. In the group treated with adjuvant radiotherapy, 14.8% of the patients experienced acute tracheal or esophageal side effects. Late toxicity (mouth dryness, skin and/or muscle fibrosis) was recorded only in a small percentage of the patients (2.4%). CONCLUSIONS: Adjuvant RT resulted in a statistically significant improvement (p < 0.01) in survival of patients with extracapsular diffusion of the cancer, especially those with pT4 N1b tumors or tumors involving the trachea.

Small cell bronchogenic carcinoma: a cyclical alternating combination of epirubicin plus cisplatin and cyclophosphamide plus etoposide.

Forty-seven patients with advanced small-cell bronchogenic carcinoma (SCLC) were treated with a combination of epirubicin (4-EPIDX) (60 mg/m2 i.v.) and cisplatin (CDDP) (50 mg/m2 i.v.) on day 1, alternated with cyclophosphamide (CTX) (800 mg/m2 i.v.) day 1 and etoposide (VP16) (120 mg/m2 i.v.) on days 21-23. Four patients (9%) obtained a complete remission and 27 (57%) a partial remission with an overall remission rate of 66%. The median duration of response was 37 weeks (range 13-150) and the median duration of survival was 43 weeks (range 10-150). No severe bone marrow depression was noted. The other side-effects were of a mild grade.